Details for New Drug Application (NDA): 217370
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NDA 217370 describes TRYPTYR, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the TRYPTYR profile page.
The generic ingredient in TRYPTYR is acoltremon. One supplier is listed for this compound. Additional details are available on the acoltremon profile page.
The generic ingredient in TRYPTYR is acoltremon. One supplier is listed for this compound. Additional details are available on the acoltremon profile page.
Summary for 217370
| Tradename: | TRYPTYR |
| Applicant: | Alcon Labs Inc |
| Ingredient: | acoltremon |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217370
Generic Entry Date for 217370*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 217370
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRYPTYR | acoltremon | SOLUTION/DROPS;OPHTHALMIC | 217370 | NDA | Alcon Laboratories, Inc. | 0065-8595 | 0065-8595-01 | 3 POUCH in 1 CARTON (0065-8595-01) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL |
| TRYPTYR | acoltremon | SOLUTION/DROPS;OPHTHALMIC | 217370 | NDA | Alcon Laboratories, Inc. | 0065-8595 | 0065-8595-02 | 12 POUCH in 1 CARTON (0065-8595-02) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.003% | ||||
| Approval Date: | May 28, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 28, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 16, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | ||||||||
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